A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

369 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2025-12-30

Brief Summary

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A randomized, double-blind, positive controlled phase III study to evaluate the efficacy and safety of BPI-7711 capsule in locally advanced or recurrent/metastatic treatment-naïve non-small cell lung cancer patients with EGFR mutation

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Detailed Description

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This is a Phase III clinical study, which aims to compare the efficacy and safety of BPI-7711 capsule and gefitinib tablet in the treatment of initially-treated patients with locally advanced or recurrent metastatic with EGFR mutation.

Conditions

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NSCLC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BPI-7711

180 mg BPI-7711 capsule + 250mg gefitinib placebo tablet, QD

Group Type EXPERIMENTAL

BPI-7711

Intervention Type DRUG

180 mg, oral, QD

Placebo Tablet

Intervention Type DRUG

250 mg gefitinib placebo tablet, QD

Gefitinib

180 mg BPI-7711 placebo capsule + 250mg gefitinib tablet, QD

Group Type ACTIVE_COMPARATOR

Gefitinib

Intervention Type DRUG

250 mg, oral, QD

Placebo capsule

Intervention Type DRUG

180 mg BPI-7711 placebo capsule, QD

Interventions

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BPI-7711

180 mg, oral, QD

Intervention Type DRUG

Gefitinib

250 mg, oral, QD

Intervention Type DRUG

Placebo Tablet

250 mg gefitinib placebo tablet, QD

Intervention Type DRUG

Placebo capsule

180 mg BPI-7711 placebo capsule, QD

Intervention Type DRUG

Other Intervention Names

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BPI-7711 capsule Iressa placebo placebo

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed non-small cell lung cancer.
* The ECOG score of performance status is 0-1.
* Locally advanced or recurrent metastatic NSCLC that has never received systemic treatment.
* According to RECIST1.1 criteria, there is at least 1 measurable lesion that has not been previously irradiated.
* Prior to enrollment, a central laboratory testing report has confirmed that the tumor has one of two common EGFR mutations positive that are sensitive to EGFR-TKI therapy, accompanied with or not accompanied with other EGFR mutation, with the exception of exon 20 insertion.

Exclusion Criteria

* Previously received systemic treatment for locally advanced or recurrent metastatic cancer.
* Primary T790M mutation-positive patient.
* Previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring hormonal therapy, or any clinically proven active interstitial lung disease.
* Known active infections such as hepatitis B, hepatitis C, and human immunodeficiency virus.
* Local radiation therapy is carried out within 1 week; more than 30% bone marrow radiation therapy or extensive radiation therapy is performed within 4 weeks.
* ≤ 4 weeks from major surgery or ≤ 2 weeks from minor surgery.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No